MESACUP ANA TEST

IVD-In Vitro Diagnostic Use CE marked

Instructions for use

The MESACUP ANA TEST is semi-quantitative enzyme-linked immunosorbent assay (ELISA) for the detection of disease specific anti-Nuclear antibodies in human serum.

Background:

Antinuclear antibodies (ANA) are autoantibodies against various cell nucleus antigens and some of them are considered to be useful for diagnosis for autoimmune diseases such as Systemic Lupus Erythematosus (SLE), Mixed Connective Tissue Disease (MCTD), Sjögren’s Syndrome (SjS), Progressive Systemic Sclerosis (PSS). Indirect immunofluorescence (IF) has been used widely to detect antinuclear antibodies. As the corresponding antigen can be presumed by staining pattern, it can yield information on a variety of autoantibody specificities. On the other hand, it is inconvenient when many samples are examined and it sometimes lacks assay specificity due to difference among reagents, operators and laboratory equipment.

The MESACUP ANA TEST is a ELISA format test to detect disease specific antinuclear antibodies which are frequently observed in patients with autoimmune diseases. This test makes it possible to have objective interpretation since the results are expressed as Unit value and examines many samples in a short period of time.

Principle:

The MESACUP ANA TEST measures disease specific antinuclear antibodies, anti RNP, Sm, SS-A, SS-B, Scl-70, Jo-1, CENP-B, Ribosomal-P, DNA and Histone antibodies present in the serum by ELISA. Calibrators and patient serum are added to microwell coated with antigens, allowing antinuclear antibodies to react with the immobilized antigens (Sample incubation). After wash to remove any unbound serum proteins, horseradish peroxidase conjugated anti human IgG, IgA and IgM are added and incubated (Conjugate incubation). Following another washing step, the peroxidase substrate is added and incubated for an additional period of time (Substrate incubation). Acid solution is then added to each well to terminate the enzyme reaction and to stabilize the color development. The assay can be quantified by measuring the reaction photometrically and plotting the results.

Size: 96 wells

Method: ELISA

Antigen: a mixture of recombinant purified proteins of Jo-1, RNP, SS-A, SS-B, CENP-B, Ribosomal P, in vitro transcribed U1 RNA, native purified proteins of SS-A, Sm, Scl-70, DNA and Histone

Availability: all regions